Effectiveness and safety of the conversion to MeltDose® extended‐release tacrolimus from other formulations of tacrolimus in stable kidney transplant patients: A retrospective study
Tacrolimus is the cornerstone of immunosuppressive therapy after kidney transplantation. Its narrow therapeutic window mandates serum level strict monitoring and dose adjustments to ensure the optimal risk‐benefit balance. This observational retrospective study analyzed the effectiveness and safety...
Gespeichert in:
| Veröffentlicht in: | Clinical transplantation 2020-01, Vol.34 (1), p.e13767-n/a |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | n/a |
|---|---|
| container_issue | 1 |
| container_start_page | e13767 |
| container_title | Clinical transplantation |
| container_volume | 34 |
| creator | Sánchez Fructuoso, Ana Ruiz, Juan Carlos Franco, Antonio Diekmann, Fritz Redondo, Dolores Calviño, Jesús Serra, Nuria Aladrén, María José Cigarrán, Secundino Manonelles, Ana Ramos, Ana Gómez, Gonzalo González Posada, José Manuel Andrés, Amado Beneyto, Isabel Muñiz, Andrés López Perelló, Manel Lauzurica, Ricardo |
| description | Tacrolimus is the cornerstone of immunosuppressive therapy after kidney transplantation. Its narrow therapeutic window mandates serum level strict monitoring and dose adjustments to ensure the optimal risk‐benefit balance. This observational retrospective study analyzed the effectiveness and safety of conversion from twice‐daily immediate‐release tacrolimus (IR‐Tac) or once‐daily prolonged‐release tacrolimus (PR‐Tac) to the recent formulation once‐daily MeltDose® extended‐release tacrolimus (LCP‐Tac) in 365 stable kidney transplant recipients. We compared kidney function three months before and three months after the conversion. Three months after conversion, the total daily dose was reduced ~35% (P |
| doi_str_mv | 10.1111/ctr.13767 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7050537</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2322817033</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4157-91827346aa22d0963b84f5c416979fb2392f2e3c262a631d2beca2eae24a5a6f3</originalsourceid><addsrcrecordid>eNp1kbtuFDEUhi0EIkug4AWQS1Js4suOZ4cCKVrCRQpCQqG2PDPHxOCxFx_PwnQ8Ak9CTZ1HyZNgMiFAgRtbPp8_H_sn5CFnh7yMoy6nQy5rVd8iCy6bZskYF7fJgjVMlLWSe-Qe4oeyq7iq7pI9yde8kpwtyI8Ta6HLbgcBEKkJPUVjIU80WprPgXYx7CChi4HmSF-Dz88iwsV3Cl8yhB76y6_fEngwCDSbLkXvhhGpTXGgsQgStTENoze5KPDK-odygWI2rQf60fUBJpqTCbj1JmS6LScgZHxCj2mCnCJu50bLkbGf7pM71niEB9fzPnn3_ORs83J5-ubFq83x6bJb8apeNnwtarlSxgjRs0bJdr2yVamppm5sK2QjrADZCSWMkrwXLXRGgAGxMpVRVu6Tp7N3O7YD9F1pKRmvt8kNJk06Gqf_rQR3rt_Hna5ZxSpZF8Hja0GKn0bArAeHHfjySIgjaiGFWPOaSVnQgxktH4SYwN5cw5n-lbQuSeurpAv76O--bsjf0RbgaAY-Ow_T_016c_Z2Vv4EuwW7Ow</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2322817033</pqid></control><display><type>article</type><title>Effectiveness and safety of the conversion to MeltDose® extended‐release tacrolimus from other formulations of tacrolimus in stable kidney transplant patients: A retrospective study</title><source>Wiley Online Library All Journals</source><creator>Sánchez Fructuoso, Ana ; Ruiz, Juan Carlos ; Franco, Antonio ; Diekmann, Fritz ; Redondo, Dolores ; Calviño, Jesús ; Serra, Nuria ; Aladrén, María José ; Cigarrán, Secundino ; Manonelles, Ana ; Ramos, Ana ; Gómez, Gonzalo ; González Posada, José Manuel ; Andrés, Amado ; Beneyto, Isabel ; Muñiz, Andrés López ; Perelló, Manel ; Lauzurica, Ricardo</creator><creatorcontrib>Sánchez Fructuoso, Ana ; Ruiz, Juan Carlos ; Franco, Antonio ; Diekmann, Fritz ; Redondo, Dolores ; Calviño, Jesús ; Serra, Nuria ; Aladrén, María José ; Cigarrán, Secundino ; Manonelles, Ana ; Ramos, Ana ; Gómez, Gonzalo ; González Posada, José Manuel ; Andrés, Amado ; Beneyto, Isabel ; Muñiz, Andrés López ; Perelló, Manel ; Lauzurica, Ricardo</creatorcontrib><description>Tacrolimus is the cornerstone of immunosuppressive therapy after kidney transplantation. Its narrow therapeutic window mandates serum level strict monitoring and dose adjustments to ensure the optimal risk‐benefit balance. This observational retrospective study analyzed the effectiveness and safety of conversion from twice‐daily immediate‐release tacrolimus (IR‐Tac) or once‐daily prolonged‐release tacrolimus (PR‐Tac) to the recent formulation once‐daily MeltDose® extended‐release tacrolimus (LCP‐Tac) in 365 stable kidney transplant recipients. We compared kidney function three months before and three months after the conversion. Three months after conversion, the total daily dose was reduced ~35% (P < .0001), and improved bioavailability and stable serum LCP‐Tac concentrations were observed. There was no increase in the number of patients requiring tacrolimus dose adjustments after conversion. Renal function was unaltered, and no cases of BPAR were reported. Reports of tremors, as collected in the clinical histories for each patient, decreased from pre‐conversion (20.8%) to post‐conversion (11.8%, P < .0001). LCP‐Tac generated a cost reduction of 63% compared with PR‐Tac. In conclusion, the conversion strategy to LCP‐Tac from other tacrolimus formulations in stable kidney transplant patients showed safety and effectiveness in a real‐world setting, confirming the data from RCTs. The specific pharmacokinetic properties of LCP‐Tac could be potentially advantageous in patients with tacrolimus‐related adverse events.</description><identifier>ISSN: 0902-0063</identifier><identifier>EISSN: 1399-0012</identifier><identifier>DOI: 10.1111/ctr.13767</identifier><identifier>PMID: 31815310</identifier><language>eng</language><publisher>Denmark: John Wiley and Sons Inc</publisher><subject>extended‐release tacrolimus ; immediate‐release tacrolimus ; kidney transplant ; LCPT ; Original ; prolonged‐release tacrolimus ; tacrolimus</subject><ispartof>Clinical transplantation, 2020-01, Vol.34 (1), p.e13767-n/a</ispartof><rights>2019 The Authors. published by John Wiley & Sons Ltd</rights><rights>2019 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4157-91827346aa22d0963b84f5c416979fb2392f2e3c262a631d2beca2eae24a5a6f3</citedby><cites>FETCH-LOGICAL-c4157-91827346aa22d0963b84f5c416979fb2392f2e3c262a631d2beca2eae24a5a6f3</cites><orcidid>0000-0002-7904-8730 ; 0000-0003-3330-2673</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.13767$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fctr.13767$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,1417,27923,27924,45573,45574</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31815310$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sánchez Fructuoso, Ana</creatorcontrib><creatorcontrib>Ruiz, Juan Carlos</creatorcontrib><creatorcontrib>Franco, Antonio</creatorcontrib><creatorcontrib>Diekmann, Fritz</creatorcontrib><creatorcontrib>Redondo, Dolores</creatorcontrib><creatorcontrib>Calviño, Jesús</creatorcontrib><creatorcontrib>Serra, Nuria</creatorcontrib><creatorcontrib>Aladrén, María José</creatorcontrib><creatorcontrib>Cigarrán, Secundino</creatorcontrib><creatorcontrib>Manonelles, Ana</creatorcontrib><creatorcontrib>Ramos, Ana</creatorcontrib><creatorcontrib>Gómez, Gonzalo</creatorcontrib><creatorcontrib>González Posada, José Manuel</creatorcontrib><creatorcontrib>Andrés, Amado</creatorcontrib><creatorcontrib>Beneyto, Isabel</creatorcontrib><creatorcontrib>Muñiz, Andrés López</creatorcontrib><creatorcontrib>Perelló, Manel</creatorcontrib><creatorcontrib>Lauzurica, Ricardo</creatorcontrib><title>Effectiveness and safety of the conversion to MeltDose® extended‐release tacrolimus from other formulations of tacrolimus in stable kidney transplant patients: A retrospective study</title><title>Clinical transplantation</title><addtitle>Clin Transplant</addtitle><description>Tacrolimus is the cornerstone of immunosuppressive therapy after kidney transplantation. Its narrow therapeutic window mandates serum level strict monitoring and dose adjustments to ensure the optimal risk‐benefit balance. This observational retrospective study analyzed the effectiveness and safety of conversion from twice‐daily immediate‐release tacrolimus (IR‐Tac) or once‐daily prolonged‐release tacrolimus (PR‐Tac) to the recent formulation once‐daily MeltDose® extended‐release tacrolimus (LCP‐Tac) in 365 stable kidney transplant recipients. We compared kidney function three months before and three months after the conversion. Three months after conversion, the total daily dose was reduced ~35% (P < .0001), and improved bioavailability and stable serum LCP‐Tac concentrations were observed. There was no increase in the number of patients requiring tacrolimus dose adjustments after conversion. Renal function was unaltered, and no cases of BPAR were reported. Reports of tremors, as collected in the clinical histories for each patient, decreased from pre‐conversion (20.8%) to post‐conversion (11.8%, P < .0001). LCP‐Tac generated a cost reduction of 63% compared with PR‐Tac. In conclusion, the conversion strategy to LCP‐Tac from other tacrolimus formulations in stable kidney transplant patients showed safety and effectiveness in a real‐world setting, confirming the data from RCTs. The specific pharmacokinetic properties of LCP‐Tac could be potentially advantageous in patients with tacrolimus‐related adverse events.</description><subject>extended‐release tacrolimus</subject><subject>immediate‐release tacrolimus</subject><subject>kidney transplant</subject><subject>LCPT</subject><subject>Original</subject><subject>prolonged‐release tacrolimus</subject><subject>tacrolimus</subject><issn>0902-0063</issn><issn>1399-0012</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><recordid>eNp1kbtuFDEUhi0EIkug4AWQS1Js4suOZ4cCKVrCRQpCQqG2PDPHxOCxFx_PwnQ8Ak9CTZ1HyZNgMiFAgRtbPp8_H_sn5CFnh7yMoy6nQy5rVd8iCy6bZskYF7fJgjVMlLWSe-Qe4oeyq7iq7pI9yde8kpwtyI8Ta6HLbgcBEKkJPUVjIU80WprPgXYx7CChi4HmSF-Dz88iwsV3Cl8yhB76y6_fEngwCDSbLkXvhhGpTXGgsQgStTENoze5KPDK-odygWI2rQf60fUBJpqTCbj1JmS6LScgZHxCj2mCnCJu50bLkbGf7pM71niEB9fzPnn3_ORs83J5-ubFq83x6bJb8apeNnwtarlSxgjRs0bJdr2yVamppm5sK2QjrADZCSWMkrwXLXRGgAGxMpVRVu6Tp7N3O7YD9F1pKRmvt8kNJk06Gqf_rQR3rt_Hna5ZxSpZF8Hja0GKn0bArAeHHfjySIgjaiGFWPOaSVnQgxktH4SYwN5cw5n-lbQuSeurpAv76O--bsjf0RbgaAY-Ow_T_016c_Z2Vv4EuwW7Ow</recordid><startdate>202001</startdate><enddate>202001</enddate><creator>Sánchez Fructuoso, Ana</creator><creator>Ruiz, Juan Carlos</creator><creator>Franco, Antonio</creator><creator>Diekmann, Fritz</creator><creator>Redondo, Dolores</creator><creator>Calviño, Jesús</creator><creator>Serra, Nuria</creator><creator>Aladrén, María José</creator><creator>Cigarrán, Secundino</creator><creator>Manonelles, Ana</creator><creator>Ramos, Ana</creator><creator>Gómez, Gonzalo</creator><creator>González Posada, José Manuel</creator><creator>Andrés, Amado</creator><creator>Beneyto, Isabel</creator><creator>Muñiz, Andrés López</creator><creator>Perelló, Manel</creator><creator>Lauzurica, Ricardo</creator><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-7904-8730</orcidid><orcidid>https://orcid.org/0000-0003-3330-2673</orcidid></search><sort><creationdate>202001</creationdate><title>Effectiveness and safety of the conversion to MeltDose® extended‐release tacrolimus from other formulations of tacrolimus in stable kidney transplant patients: A retrospective study</title><author>Sánchez Fructuoso, Ana ; Ruiz, Juan Carlos ; Franco, Antonio ; Diekmann, Fritz ; Redondo, Dolores ; Calviño, Jesús ; Serra, Nuria ; Aladrén, María José ; Cigarrán, Secundino ; Manonelles, Ana ; Ramos, Ana ; Gómez, Gonzalo ; González Posada, José Manuel ; Andrés, Amado ; Beneyto, Isabel ; Muñiz, Andrés López ; Perelló, Manel ; Lauzurica, Ricardo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4157-91827346aa22d0963b84f5c416979fb2392f2e3c262a631d2beca2eae24a5a6f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>extended‐release tacrolimus</topic><topic>immediate‐release tacrolimus</topic><topic>kidney transplant</topic><topic>LCPT</topic><topic>Original</topic><topic>prolonged‐release tacrolimus</topic><topic>tacrolimus</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sánchez Fructuoso, Ana</creatorcontrib><creatorcontrib>Ruiz, Juan Carlos</creatorcontrib><creatorcontrib>Franco, Antonio</creatorcontrib><creatorcontrib>Diekmann, Fritz</creatorcontrib><creatorcontrib>Redondo, Dolores</creatorcontrib><creatorcontrib>Calviño, Jesús</creatorcontrib><creatorcontrib>Serra, Nuria</creatorcontrib><creatorcontrib>Aladrén, María José</creatorcontrib><creatorcontrib>Cigarrán, Secundino</creatorcontrib><creatorcontrib>Manonelles, Ana</creatorcontrib><creatorcontrib>Ramos, Ana</creatorcontrib><creatorcontrib>Gómez, Gonzalo</creatorcontrib><creatorcontrib>González Posada, José Manuel</creatorcontrib><creatorcontrib>Andrés, Amado</creatorcontrib><creatorcontrib>Beneyto, Isabel</creatorcontrib><creatorcontrib>Muñiz, Andrés López</creatorcontrib><creatorcontrib>Perelló, Manel</creatorcontrib><creatorcontrib>Lauzurica, Ricardo</creatorcontrib><collection>Wiley-Blackwell Open Access Titles</collection><collection>Wiley Free Content</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sánchez Fructuoso, Ana</au><au>Ruiz, Juan Carlos</au><au>Franco, Antonio</au><au>Diekmann, Fritz</au><au>Redondo, Dolores</au><au>Calviño, Jesús</au><au>Serra, Nuria</au><au>Aladrén, María José</au><au>Cigarrán, Secundino</au><au>Manonelles, Ana</au><au>Ramos, Ana</au><au>Gómez, Gonzalo</au><au>González Posada, José Manuel</au><au>Andrés, Amado</au><au>Beneyto, Isabel</au><au>Muñiz, Andrés López</au><au>Perelló, Manel</au><au>Lauzurica, Ricardo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness and safety of the conversion to MeltDose® extended‐release tacrolimus from other formulations of tacrolimus in stable kidney transplant patients: A retrospective study</atitle><jtitle>Clinical transplantation</jtitle><addtitle>Clin Transplant</addtitle><date>2020-01</date><risdate>2020</risdate><volume>34</volume><issue>1</issue><spage>e13767</spage><epage>n/a</epage><pages>e13767-n/a</pages><issn>0902-0063</issn><eissn>1399-0012</eissn><abstract>Tacrolimus is the cornerstone of immunosuppressive therapy after kidney transplantation. Its narrow therapeutic window mandates serum level strict monitoring and dose adjustments to ensure the optimal risk‐benefit balance. This observational retrospective study analyzed the effectiveness and safety of conversion from twice‐daily immediate‐release tacrolimus (IR‐Tac) or once‐daily prolonged‐release tacrolimus (PR‐Tac) to the recent formulation once‐daily MeltDose® extended‐release tacrolimus (LCP‐Tac) in 365 stable kidney transplant recipients. We compared kidney function three months before and three months after the conversion. Three months after conversion, the total daily dose was reduced ~35% (P < .0001), and improved bioavailability and stable serum LCP‐Tac concentrations were observed. There was no increase in the number of patients requiring tacrolimus dose adjustments after conversion. Renal function was unaltered, and no cases of BPAR were reported. Reports of tremors, as collected in the clinical histories for each patient, decreased from pre‐conversion (20.8%) to post‐conversion (11.8%, P < .0001). LCP‐Tac generated a cost reduction of 63% compared with PR‐Tac. In conclusion, the conversion strategy to LCP‐Tac from other tacrolimus formulations in stable kidney transplant patients showed safety and effectiveness in a real‐world setting, confirming the data from RCTs. The specific pharmacokinetic properties of LCP‐Tac could be potentially advantageous in patients with tacrolimus‐related adverse events.</abstract><cop>Denmark</cop><pub>John Wiley and Sons Inc</pub><pmid>31815310</pmid><doi>10.1111/ctr.13767</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-7904-8730</orcidid><orcidid>https://orcid.org/0000-0003-3330-2673</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0902-0063 |
| ispartof | Clinical transplantation, 2020-01, Vol.34 (1), p.e13767-n/a |
| issn | 0902-0063 1399-0012 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7050537 |
| source | Wiley Online Library All Journals |
| subjects | extended‐release tacrolimus immediate‐release tacrolimus kidney transplant LCPT Original prolonged‐release tacrolimus tacrolimus |
| title | Effectiveness and safety of the conversion to MeltDose® extended‐release tacrolimus from other formulations of tacrolimus in stable kidney transplant patients: A retrospective study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-09T06%3A12%3A28IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effectiveness%20and%20safety%20of%20the%20conversion%20to%20MeltDose%C2%AE%20extended%E2%80%90release%20tacrolimus%20from%20other%20formulations%20of%20tacrolimus%20in%20stable%20kidney%20transplant%20patients:%20A%20retrospective%20study&rft.jtitle=Clinical%20transplantation&rft.au=S%C3%A1nchez%20Fructuoso,%20Ana&rft.date=2020-01&rft.volume=34&rft.issue=1&rft.spage=e13767&rft.epage=n/a&rft.pages=e13767-n/a&rft.issn=0902-0063&rft.eissn=1399-0012&rft_id=info:doi/10.1111/ctr.13767&rft_dat=%3Cproquest_pubme%3E2322817033%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2322817033&rft_id=info:pmid/31815310&rfr_iscdi=true |